Method for addressing medical conditions through a wearable health monitor with the aid of a digital computer

ABSTRACT

Individuals who suffer from certain kinds of medical conditions, particularly conditions that only sporadically exhibit measurable symptoms, can feel helpless in their attempts to secure access to medical care because, at least in part, they are left to the mercy of their condition to present symptoms at the right time to allow diagnosis and treatment. Providing these individuals with ambulatory extended-wear health monitors that record ECG and physiology, preferably available over-the-counter and without health insurance preauthorization, is a first step towards addressing their needs. In addition, these individuals need a way to gain entry into the health care system once a medically-actionable medical condition has been identified. Here, the ECG and physiology is downloaded and evaluated post-monitoring against medical diagnostic criteria. Medical specialists are pre-identified and paired up with key diagnostic findings, such that an individual whose monitoring data indicates a medical concern will be automatically referred and treated.

FIELD

This application relates in general to wearable health monitors and, inparticular, to a method for addressing medical conditions through awearable health monitor with the aid of a digital computer.

BACKGROUND

Ensuring ready access to health care remains a pressing concern in ourincreasingly fast-paced society, but the ever climbing costs of healthcare makes having health insurance or similar financial arrangements allbut essential for practically everyone except the wealthy or destitute.For the insured, the average health insurance carrier effectively servesas the gatekeeper that controls entry into the health care system andwho manages the provisioning or denial of health care by stipulating theterms under which benefits will be paid. Thusly, health insurancesubscribers (or enrollees) are at times caught in the middle between thedictates of their insurer and their ability to readily address theirhealth concerns. On the one hand, a subscriber who bypasses his primarycare provider, as typically required by an insurer as a first contact,and instead seeks out a medical specialist on his own may be taking afinancial risk, as a health insurer could deny coverage. On the otherhand, the primary care provider may not always offer a satisfactory orpracticable solution, particularly in situations where a condition hassymptoms that are transient or infrequent, or which underlies a disorderwith a long incubatory or onset period, as can happen with certainchronic conditions.

For instance, cardiac rhythm disorders may present with lightheadedness,fainting, chest pain, hypoxia, syncope, palpitations, and congestiveheart failure (CHF), yet cardiac rhythm disorders are often sporadic inoccurrence and may not show up in-clinic during a conventional 12-secondelectrocardiogram (ECG). Moreover, some types of cardiac rhythmdisorders may warrant immediate subspecialist care, such as heartblockage, tachycardia and bradycardia, which require the attention of anelectrophysiologist. Continuous ambulatory ECG monitoring over anextended period is more apt to capture sporadic cardiac events, yethealth insurers often require a primary care referral to a monitoringlaboratory before underwriting long-term ECG monitoring and access to aspecialist may be delayed or denied, depending upon the ECG monitoringresults.

Notwithstanding, if a subscriber's ECG could be recorded in anambulatory setting over a prolonged time period, particularly for aslong as seven days or more, thereby allowing the subscriber to engage inactivities of daily living, the chances of acquiring meaningful medicalinformation and capturing an abnormal event while the subscriber isengaged in normal activities are vastly improved. Unfortunately, few, ifany, options for long-term ambulatory ECG monitoring that a subscribercould undertake on his own are available, and existing ECG monitoringsolutions require physician involvement with tacit insurer approval. Forinstance, Holter monitors are widely used for extended ECG monitoring,typically for 24-48 hour time periods. A typical Holter monitor is awearable and portable version of an ECG and, as such, is cumbersome,expensive and typically available for use only through a prescription,which limits their usability, and the discretion to refer the subscriberstill remains with the attending physician.

Similarly, the ZIO XT Patch and ZIO Event Card devices, manufactured byiRhythm Tech., Inc., San Francisco, Calif., are wearable monitoringdevices that are typically worn on the upper left pectoral region torespectively provide continuous and looping ECG recording. The locationis used to simulate surgically implanted monitors. The ZIO XT Patchdevice is limited to a 14-day period, while just the electrodes of theZIO Event Card device can be worn for up to 30 days. Both devicesrepresent compromises between length of wear and quality of ECGmonitoring. Moreover, both of these devices are also prescription-only,which limits their usability and, the same as a Holter monitor, thediscretion to refer the subscriber remains with the attending physician.

Therefore, a need remains for a low cost monitor for recording an ECGand other physiology that can be used by an individual on their own,without health insurance pre-authorization, yet which can identify andgenerate an actionable, health condition-specific (and ideally healthinsurance-payable) referral to a medical specialist when medicallyappropriate.

SUMMARY

Certain kinds of medical conditions, particularly conditions that onlysporadically exhibit measurable symptoms, defy conventional forms ofmedical diagnosis centered on in-clinic testing. Individuals who sufferfrom such conditions can feel helpless in their attempts to secureaccess to medical care because, at least in part, they are left to themercy of their condition to present symptoms at the right time to allowdiagnosis and treatment. Moreover, such individuals may present to aphysician or other health care provider unable to providestate-of-the-art care for cardiac conditions, especially cardiac rhythmdisorders. Providing these individuals with ambulatory extended-wearhealth monitors that record ECG and physiology, preferably availableover-the-counter and without health insurance preauthorization, is afirst step towards addressing their needs expeditiously. In addition,these individuals need a way to gain entry into the health care systemonce a medically-actionable medical condition has been identified. Here,the ECG and physiology is downloaded and evaluated post-monitoringagainst medical diagnostic criteria. Medical specialists arepre-identified and paired up with key diagnostic findings, such that anindividual whose monitoring data indicates a medical concern will beautomatically referred and scheduled for a consultation, therebyremoving delays and bypassing intermediaries who will not providedefinitive interventions for the patient.

One embodiment provides a health monitoring apparatus for addressingmedical conditions with the aid of a digital computer. A wearable healthmonitor includes an electrode patch having a plurality of electrodesprovided to sense a patient's physiology and is adapted to be worn overa monitoring period. The wearable health monitor also includes a monitorrecorder capable of recording the physiology throughout the monitoringperiod into an onboard memory. A download station includes an interfaceover which the physiology can be downloaded from the onboard memory ofthe wearable heath monitor upon completion of the monitoring period. Acomputer is adapted to be interfaced to the download station andincludes a database including the physiology as retrieved from thedownload station and a medical diagnostic criteria. The computer alsoincludes a processor and a memory configured to store code executable bythe processor. A comparison module is configured to compare thephysiology to the medical diagnostic criteria and to generate adiagnostic overread that comprises one or more diagnostic findings. Areferral module is configured to determine the severity of any medicalcondition indicated by the diagnostic findings and to refer the patientto one or more pre-identified care providers via the computer forfacilitated diagnosis as conditioned upon the severity of each suchmedical condition that exceeds a threshold tolerance level.

A further embodiment provides a method for addressing medical conditionsthrough a wearable health monitor with the aid of a digital computer. Apatient's physiology is sensed through a wearable health monitor adaptedto be worn over a monitoring period. The physiology is recordedthroughout the monitoring period into a memory onboard the wearablehealth monitor. The physiology is downloaded into a computer uponcompletion of the monitoring period and compared to a medical diagnosticcriteria. A diagnostic overread is generated with the computer thatincludes one or more diagnostic findings. The severity of any medicalcondition indicated by the diagnostic findings is determined with thecomputer. The patient is referred to one or more pre-identified careproviders via the computer for facilitated diagnosis as conditioned uponthe severity of each such medical condition that exceeds a thresholdtolerance level.

Still other embodiments will become readily apparent to those skilled inthe art from the following detailed description, wherein are describedembodiments by way of illustrating the best mode contemplated. As willbe realized, other and different embodiments are possible and theembodiments' several details are capable of modifications in variousobvious respects, all without departing from their spirit and the scope.Accordingly, the drawings and detailed description are to be regarded asillustrative in nature and not as restrictive.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a process flow diagram showing, by way of example, one priorart approach to addressing medical conditions in a managed care model ofhealth insurance.

FIGS. 2 and 3 are diagrams showing, by way of examples, an extended wearelectrocardiography and physiological wearable monitor respectivelyfitted to the sternal region of a female patient and a male patient.

FIG. 4 is a perspective view showing a contact-activated extended wearelectrode patch with a monitor recorder inserted.

FIG. 5 is a perspective view showing the monitor recorder of FIG. 4.

FIG. 6 is a functional block diagram showing a system for addressingmedical conditions with the aid of a digital computer through themonitor recorder of FIG. 4, in accordance with one embodiment.

FIG. 7 is a process flow diagram showing a method addressing medicalconditions through a wearable health monitor with the aid of a digitalcomputer in accordance with one embodiment.

DETAILED DESCRIPTION

For certain types of medical conditions, gaining access to health carecan be a time-consuming and often frustrating experience. In the case ofcardiac rhythm disorders, such delays can cause death. One possiblereason stems from the restrictions often imposed on subscribers of bothprivate and government mandated health insurance, especially whenprovided in the form of managed care, which employs a network ofcontracted health care providers and medical facilities that arestructured to control costs and help to improve overall quality of care.FIG. 1 is a process flow diagram showing, by way of example, one priorart approach to addressing medical conditions in a managed care model 1of health insurance. In this model, the average health insurancecarrier, such as those provided by the Affordable Care Act, effectivelyserves as the gatekeeper that controls entry into the health care systemand who manages the provisioning or denial of health care by stipulatingthe terms under which benefits will be paid. At times, the goals of thehealth insurer as the arbiter of benefits can be at odds with themedical concerns of their subscribers, who are generally expected tocomply with their insurer's guidelines to receive care for non-urgenthealth conditions, or to seek an exception, preferably beforehand.

The managed care model 1 of health insurance can work well in providingaccess to care for those subscribers who are able to be served by thenetwork of health care providers and facilities that has been set up bythe health insurer to address the majority of expected health concerns.For example, for non-urgent, undiagnosed physical ailments and healthconditions, a health insurer will generally require a subscribersuffering symptoms (step 2) to see their primary care provider first(step 3). The subscriber may undergo testing (step 4) and follow up withthe primary care provider (step 3) with the expectation that most healthconditions can be resolved without departing from the primary carelevel. When circumstances dictate, the subscriber may be referred to amedical specialist (step 5); ordinarily, a showing of medical necessitywill be required before the health insurer will be contractuallyobligated to pay benefits. The type of medical specialist to whom thesubscriber is referred is based upon the primary care provider'sunderstanding of the health condition, experience, and referral network,which may be biased towards the health care provider network already setin place. At its best, such a system may still cause considerable delaysin diagnosis and management of a cardiac rhythm disorder or otherserious physiological condition.

The managed care model 1 can begin to fail when health insurancesubscribers encounter medical conditions that depart from the expectednorm, particularly medical conditions whose symptoms are transient orinfrequent, or which underlie a disorder with a long incubatory or onsetperiod, such as heart disease, diabetes mellitus, epilepsy, Parkinson'sdisease, and Alzheimer's disease. The cycle of having symptoms (step 2),seeing a primary care provider (step 3), undergoing testing (step 4),and perhaps receiving a medical specialist referral (step 5) may berepeated several times until the health condition either resolves on itsown (step 2), is diagnosed and treated at the primary care level (step3), or possibly worsens, perhaps significantly, such that interventionby a medical specialist is necessary (step 6), albeit at the cost ofpotentially complicating treatment, endangering cure or effectivemanagement, increasing medical costs, and negatively affecting qualityor duration of life.

In these situations, access to care is hindered, at least in part, bythe difficulty of or inability to narrow down the cause of the symptomsthrough in-clinic testing. Repetitions of the primary care cycle may notalways be efficacious; for example, in-clinic testing of a subscriber isonly effective if administered coincident to the timely occurrence of asporadically-occurring medical condition, yet such conditions, such asan abnormal heart rhythm or syncope, rarely occur on demand or whenneeded for present diagnosis. In addition, some health conditions mayrequire a level of care or medical specialization with which the primarycare provider is unversed, and a referral may not provide the reliefultimately sought. In some situations, the cycle of testing and followup may be repeatedly revisited; the subscriber may be forced to undergomore testing and delay until and if an appropriate medical specialistbecomes involved. Misdiagnosis or maldiagnosis remain potential risks.

As an example, consider the potentially life-threatening problem ofsyncope, or loss of consciousness. Syncope affects millions of Americansannually. Syncope also can be extremely difficult to diagnose becausethe condition is intermittent and gives no warning. Causes can rangefrom the relatively trivial, such as fainting from emotional excitement,to a life-threatening cardiac rhythm disorder, like transient heartblock, that if the condition were to persist, would result in death, andnot just transient loss of consciousness. Atrial fibrillation, anotherpotential cause of syncope, is extremely common and is an occult andleading cause of stroke. Most patients with syncope never see aphysician because they either dismiss the condition as a one-time event,rationalizing its import away, or struggle to see a physician of somesort, almost always a generalist, for help. Many such physicians eitherinappropriately dismiss the patient as anxious or begin the long-processto getting at the root cause. At minimum, this process requires referralto a cardiologist, who then prescribes an ECG monitor, usually thetraditional 24-hour Holter monitor, which in turn must be interpreted.The patient must then return for evaluation and possible therapy. Thedelay for each of these steps can take weeks. Often, the patient (orsometimes the doctor) gives up and returns to his “normal” life only toexperience a second episode of syncope or something worse, like a strokeor death. The better way to deal with syncope is for the patient toself-apply an over-the-counter ECG monitor at modest personal expense,yielding valuable data in a fraction of the time and cost of thetraditional approach, potential preventing a stroke or even saving thepatient's life.

The shortcomings of the managed care model 1, as well as other types ofhealth care provisioning arrangements that mandate who an individualmust see first for non-urgent, undiagnosed medical conditions, can besignificantly overcome by empowering the patient with basic self-helptools that improve access to health care. These tools include theability to perform self-monitoring of personal physiology, including ECGmonitoring, as described in the previous paragraph, and to be able totap into an automated referral network that, when medically appropriate,will connect the individual with the right specialist for the medicalconditions observed and diagnosed. Such physiological monitoring can beprovided through a wearable monitor that can be interfaced with adiagnostics computer system that can download physiology recorded by thewearable monitor and generate a medically-actionable diagnosticoverread, all without requiring the constant oversight or activeinvolvement of a health insurer or managed care system.

By way of example, using the heretofore referenced problem of syncoperesulting from a cardiac rhythm disorder, the wearable monitor includestwo components, a flexible extended wear electrode patch and a removablereusable monitor recorder. FIGS. 2 and 3 are diagrams showing, by way ofexample, an extended wear electrocardiography and physiological wearablemonitor 12, including a monitor recorder 14 in accordance with oneembodiment, respectively fitted to the sternal region of a femalepatient 10 and a male patient 11. Both the monitor recorder 14 and theelectrode patch 15 are optimized to capture electrical signals from thepropagation of low amplitude, relatively low frequency content cardiacaction potentials, particularly the P-waves generated during atrialactivation. The wearable monitor 12 could include additional sensors tomonitor and record other types of physiology, including blood pressure,respiratory rate, temperature, and blood glucose, either in addition toor in lieu of heart rate.

The wearable monitor 12 sits centrally (in the midline) on the patient'schest over the mid-sternum 13 oriented top-to-bottom with the monitorrecorder 14 preferably situated towards the patient's head. Theelectrode patch 15 is shaped to fit comfortably, conforming to thecontours of the patient's chest approximately centered on the sternalmidline 16 (or immediately to either side of the sternum 13). The distalend of the electrode patch 15 extends towards the xiphoid process and,depending upon the patient's build, may straddle the region over thexiphoid process. The proximal end of the electrode patch 15, locatedunder the monitor recorder 14, is below the manubrium and, dependingupon patient's build, may straddle the region over the manubrium.

During ECG monitoring, the amplitude and strength of action potentialssensed on the body's surface are affected to varying degrees by cardiac,cellular, and extracellular structure and activity, vector of currentflow, and physical factors, like obesity, dermatitis, large breasts, andhigh impedance skin, as can occur in dark-skinned individuals. Sensingalong the sternal midline 16 (or immediately to either side of thesternum 13) significantly improves the ability of the wearable monitor12 to cutaneously sense cardiac electric signals, particularly theP-wave (or atrial activity) and, to a lesser extent, the QRS intervalsignals in the ECG waveforms that indicate ventricular activity bycountering some of the effects of these factors, such as described incommonly-assigned U.S. patent application, entitled “AmbulatoryElectrocardiography Monitoring Patch Optimized for Capturing LowAmplitude Cardiac Action Potential Propagation,” Ser. No. 14/488,230,filed Sep. 16, 2014, pending, the disclosure of which is incorporated byreference, while simultaneously facilitating comfortable long-term wearfor many weeks. The sternum 13 overlies the right atrium of the heartand the placement of the wearable monitor 12 in the region of thesternal midline 16 puts the ECG electrodes of the electrode patch 15 ina location better adapted to sensing and recording P-wave signals thanother placement locations, say, the upper left pectoral region orlateral thoracic region or the limb leads. In addition, placing thelower or inferior pole (ECG electrode) of the electrode patch 15 over(or near) the xiphoid process facilitates sensing of ventricularactivity and provides excellent recordation of the QRS interval as thexiphoid process overlies the apical region of the ventricles.

During use, the electrode patch 15 is first adhered to the skin alongthe sternal midline 16 (or immediately to either side of the sternum13). A monitor recorder 14 is then snapped into place on the electrodepatch 15 to initiate ECG monitoring, with the monitoring being initiatedupon the recorder 14 detecting contact with the patient. (Note that themonitor can also be snapped into place on a table prior to removingadhesive liner and application of the electrode patch to the skin.) FIG.4 is a perspective view showing a contact-activated extended wearelectrode patch 15 with a monitor recorder 14 inserted. The body of theelectrode patch 15 is preferably constructed using a flexible backing 20formed as an elongated strip 21 of wrap knit or similar stretchablematerial with a narrow longitudinal mid-section 23 evenly taperinginward from both sides. A pair of cut-outs 22 between the distal andproximal ends of the electrode patch 15 create a narrow longitudinalmidsection 23 or “isthmus” and defines an elongated “hourglass”-likeshape, when viewed from above. The upper part of the “hourglass” issized to allow an electrically non-conductive receptacle 25, sits on topof the outward-facing surface of the electrode patch 15, to be affixedto the electrode patch 15 with an ECG electrode placed underneath on thepatient-facing underside, or contact, surface of the electrode patch 15;the upper part of the “hourglass” has a longer and wider profile (butstill rounded and tapered to fit comfortably between the breasts) thanthe lower part of the “hourglass,” which is sized primarily to allowjust the placement of an ECG electrode of appropriate shape and surfacearea to record the P-wave and the QRS signals sufficiently given theinter-electrode spacing.

The electrode patch 15 incorporates features that significantly improvewearability, performance, and patient comfort throughout an extendedmonitoring period for men or women. During wear, the electrode patch 15is susceptible to pushing, pulling, and torqueing movements, includingcompressional and torsional forces when the patient bends forward, andtensile and torsional forces when the patient leans backwards or twiststheir thorax. To counter these stress forces, the electrode patch 15incorporates strain and crimp reliefs, such as described incommonly-assigned U.S. patent application Publication No. 2015/0087948,published Mar. 26, 2015, pending, and U.S. patent application, entitled“Extended Wear Electrocardiography Patch,” Ser. No. 14/736,257, filedJun. 16, 2015, pending, the disclosures of which are incorporated byreference. In addition, the cut-outs 22 and longitudinal midsection 23help minimize interference with and discomfort to breast tissue,particularly in women (and gynecomastic men). The cut-outs 22 andlongitudinal midsection 23 further allow better conformity of theelectrode patch 15 to sternal bowing and to the narrow isthmus of flatskin that can occur along the bottom of the intermammary cleft betweenthe breasts, especially in buxom women. The cut-outs 22 and longitudinalmidsection 23 help the electrode patch 15 fit nicely between a pair offemale breasts in the intermammary cleft. Still other shapes, cut-outsand conformities to the electrode patch 15 are possible.

The monitor recorder 14 removably and reusably snaps into anelectrically non-conductive receptacle 25 during use. The monitorrecorder 14 contains electronic circuitry for recording and storing thepatient's electrocardiography as sensed via a pair of ECG electrodesprovided on the electrode patch 15, such as described incommonly-assigned U.S. Patent Application Publication No. 2015/0087949,published Mar. 26, 2015, pending, the disclosure which is incorporatedby reference. The non-conductive receptacle 25 is provided on the topsurface of the flexible backing 20 with a retention catch 26 and tensionclip 27 molded into the non-conductive receptacle 25 to conformablyreceive and securely hold the monitor recorder 14 in place.

The monitor recorder 14 includes a sealed housing that snaps into placein the non-conductive receptacle 25. FIG. 5 is a perspective viewshowing the monitor recorder 14 of FIG. 4. The sealed housing 50 of themonitor recorder 14 has a rounded isosceles trapezoidal-like shape 52,for comfort with women, when viewed from above, such as described incommonly-assigned U.S. Design Pat. No. D717,955, entitled“Electrocardiography Monitor,” issued Nov. 18, 2014, the disclosure ofwhich is incorporated by reference. In addition, a label, barcode, QRcode, or other visible or electronic indicia can be printed on theoutside of, applied to the outside of, or integrated into the sealedhousing 50 to uniquely identify the monitor recorder 14 and can includea serial number, manufacturing lot number, date of manufacture, and soforth. The edges 51 along the top and bottom surfaces are rounded forpatient comfort. The sealed housing 50 is approximately 47 mm long, 23mm wide at the widest point, and 7 mm high, excluding a patient-operabletactile-feedback button 55. The sealed housing 50 can be molded out ofpolycarbonate, ABS, or an alloy of those two materials. The button 55 iswaterproof and the button's top outer surface is molded silicon rubberor similar soft pliable material. A retention detent 53 and tensiondetent 54 are molded along the edges of the top surface of the housing50 to respectively engage the retention catch 26 and the tension clip 27molded into non-conductive receptacle 25. Other shapes, features, andconformities of the sealed housing 50 are possible.

The electrode patch 15 is intended to be disposable. The monitorrecorder 14, however, is reusable and can be transferred to successiveelectrode patches 15 to ensure continuity of monitoring. The placementof the wearable monitor 12 in a location at the sternal midline 16 (orimmediately to either side of the sternum 13) benefits long-termextended wear by removing the requirement that ECG electrodes becontinually placed in the same spots on the skin throughout themonitoring period. Instead, the patient is free to place an electrodepatch 15 anywhere within the general region of the sternum 13.

As a result, at any point during ECG monitoring, the patient's skin isable to recover from the wearing of an electrode patch 15, whichincreases patient comfort and satisfaction, while the monitor recorder14 ensures ECG monitoring continuity with minimal effort. A monitorrecorder 14 is merely unsnapped from a worn out electrode patch 15, theworn out electrode patch 15 is removed from the skin, a new electrodepatch 15 is adhered to the skin, possibly in a new spot immediatelyadjacent to the earlier location, and the same monitor recorder 14 issnapped into the new electrode patch 15 to reinitiate and continue theECG monitoring.

When operated standalone, the monitor recorder 14 senses and records thepatient's ECG and physiology data into an onboard memory, which can bedownloaded and evaluated to identify and generate an actionable, healthcondition-specific (and ideally health insurance-payable) referral to amedical specialist when medically appropriate. In addition, the wearablemonitor 12 can interoperate with other devices, which further improvesupon a patient's ability to address medical conditions on his own. FIG.6 is a functional block diagram showing a system 60 for addressingmedical conditions with the aid of a digital computer 62 through themonitor recorder 14 of FIG. 4, in accordance with one embodiment. In oneform, the monitor recorder 14 is a reusable component that can be fittedduring patient monitoring into a non-conductive receptacle provided onthe electrode patch 15, and later removed for offloading of stored ECGdata or to receive revised programming. The monitor recorder 14 can thenbe connected to a download station 65, which could be a dedicatedprogrammer or other device, including a digital computer, such aspersonal computer 76, that permits the retrieval of stored ECGmonitoring data, execution of diagnostics on or programming of themonitor recorder 14, or performance of other functions.

To facilitate physical connection with a download station 65, themonitor recorder 14 has a set of electrical contacts (not shown) thatenable the monitor recorder 14 to physically interface to a set ofterminals 68 on a paired receptacle 67 of the download station 65. Inturn, the download station 65 executes a communications or offloadprogram 66 (“Offload”) or similar program that interacts with themonitor recorder 14 via the physical interface to retrieve the storedECG and physiology monitoring data. The download station 65 could be aserver, personal computer, such as personal computer 76, tablet orhandheld computer, smart mobile device, or purpose-built device designedspecific to the task of interfacing with a monitor recorder 14. Stillother forms of download station 65 are possible. In a furtherembodiment, the data from the monitor 12 can be offloaded wirelessly andthe monitor 12 can interface with the download station 65 wirelessly.

The ECG and physiology data retrieved from the monitor recorder 14 bythe download station 65 can, in turn, be retrieved from the downloadstation 65 over a hard link 75 using a control program 77 (“Ctl”) oranalogous application executing on a personal computer 76 or otherconnectable computing device, via a communications link (not shown),whether wired or wireless, or by physical transfer of storage media (notshown). The personal computer 76 or other connectable device may alsoexecute middleware that converts ECG and physiology data and otherinformation into a format suitable for use by a third-partypost-monitoring analysis program. Formatted data stored on the personalcomputer 76 is maintained and safeguarded in the same manner aselectronic medical records (EMRs) 74 are protected in the securedatabase 64, as further discussed infra. In a further embodiment, thedownload station 65 is able to directly interface with other devicesover a computer communications network 61, which could be somecombination of a local area network and a wide area network, includingthe Internet or another telecommunications network, over a wired orwireless connection.

A client-server model could be used for ECG and physiology data downloadand analysis. In this model, a server 62 remotely interfaces with thedownload station 65, by way of the personal computer 76, over thenetwork 61 and retrieves the formatted data or other information. Theserver 62 executes a patient management program 63 (“Mgt”) or similarapplication that stores the retrieved formatted data and otherinformation in a secure database 64 cataloged in that patient's EMRs 74.Patients' EMRs can be supplemented with other information, such asmedical history, testing results, and so forth, which can be factoredinto automated diagnosis and referral. In addition, the patientmanagement program 63 could manage a subscription service thatauthorizes a monitor recorder 14 to operate for a set period of time orunder pre-defined operational parameters.

The patient management program 63, or other trusted application, alsomaintains and safeguards the secure database 64 to limit access topatient EMRs 74 to only authorized parties for appropriate medical orother uses, such as mandated by state or federal law, such as under theHealth Insurance Portability and Accountability Act (HIPAA) or per theEuropean Union's Data Protection Directive. For example, a physician mayseek to review and evaluate his patient's ECG monitoring data, assecurely stored in the secure database 64. The physician would executean application program 70 (“Pgm”), such as a post-monitoring ECGanalysis program, on a personal computer 69 or other connectablecomputing device, and, through the application program 70, coordinateaccess to his patient's EMRs 74 with the patient management program 63.Other schemes and safeguards to protect and maintain the integrity ofpatient EMRs 74 are possible.

In a further embodiment, the wearable monitor 12 can interoperatewirelessly with other wearable physiology monitors and activity sensors71, such as activity trackers worn on the wrist or body, and with mobiledevices 72, including smart watches and smartphones. Wearable physiologymonitors and activity sensors 71 encompass a wide range of wirelesslyinterconnectable devices that measure or monitor a patient'sphysiological data, such as heart rate, temperature, blood pressure,respiratory rate, blood pressure, blood sugar (with appropriatesubcutaneous probe), oxygen saturation, minute ventilation, and so on;physical states, such as movement, sleep, footsteps, and the like; andperformance, including calories burned or estimated blood glucose level.The physiology sensors in non-wearable mobile devices, particularlysmartphones, are generally not meant for continuous tracking and do notprovide medically precise and actionable data sufficient for a physicianto prescribe a surgical or serious drug intervention; such data can beconsidered screening information that something may be wrong, but notdata that provides the highly precise information that may allow for asurgery, such as implantation of a pacemaker for heart block or adefibrillator for ventricular tachycardia, or the application of seriousmedications, like blood thinners for atrial fibrillation or a cardiacablation procedure. Such devices, like smartphones, are better suited topre- and post-exercise monitoring or as devices that can provide asignal that something is wrong, but not in the sufficient detail andmedico-legal validation to allow for medical action. Conversely,medically actionable wearable sensors and devices sometimes providecontinuous recording for relatively short time periods, but must bepaired with a smartphone or computer to offload and evaluate therecorded data, especially if the data is of urgent concern, such asmobile cardiac outpatient telemetry devices.

Wearable physiology monitors and activity sensors 71, also known as“activity monitors,” and to a lesser extent, “fitness” sensor-equippedmobile devices 72, can trace their life-tracking origins to ambulatorydevices used within the medical community to sense and recordtraditional medical physiology that could be useful to a physician inarriving at a patient diagnosis or clinical trajectory, as well as fromoutside the medical community, from, for instance, sports or lifestyleproduct companies who seek to educate and assist individuals withself-quantifying interests. Data is typically tracked by the wearablephysiology monitors or activity sensors 71 and mobile device 72 for onlythe personal use of the wearer. The physiological monitoring is usuallyconsidered informational only, even where a device originated within themedical or health care community, in part, because the data has not been(and is not intended to be) time-correlated to physician-supervisedmonitoring. Importantly, medically-significant events, such as cardiacrhythm disorders, including tachyarrhythmias, like ventriculartachycardia or atrial fibrillation, and bradyarrhythmias, like heartblock, while potentially detectable with the appropriate diagnosticheuristics, are neither identified nor acted upon by the wearablephysiology monitors and activity sensors 71 and the mobile device 72.Nevertheless, wearable physiology monitors or activity sensors 71 andmobile device 72 may play a role in helping a patient start to address amedical concern at a lay level.

Frequently, wearable physiology monitors and activity sensors 71 arecapable of wirelessly interfacing with mobile devices 72, particularlysmart mobile devices, including so-called “smartphones” and “smartwatches,” as well as with personal computers and tablet or handheldcomputers, to download monitoring data either in real-time or inbatches. The wireless interfacing of such activity monitors is generallyachieved using transceivers that provide low-power, short-range wirelesscommunications, such as Bluetooth, although some wearable physiologymonitors and activity sensors 71, like their mobile device cohorts, havetransceivers that provide true wireless communications services,including 4G or better mobile telecommunications, over atelecommunications network. Other types of wireless and wiredinterfacing are possible.

Where the wearable physiology monitors and activity sensors 71 arepaired with a mobile device 72, the mobile device 72 executes anapplication (“App”) that can retrieve the data collected by the wearablephysiology monitor and activity sensor 71 and evaluate the data togenerate information of interest to the wearer, such as an estimation ofthe effectiveness of the wearer's exercise efforts. Where the wearablephysiology monitors and activity sensors 71 has sufficient onboardcomputational resources, the activity monitor itself executes an appwithout the need to relay data to a mobile device 72. Generally, suchmore computationally-capable wearable physiology monitors and activitysensors are also equipped with wireless communications servicestransceivers, such as found in some smart watches that combine thefeatures of activity monitors with mobile devices. Still other activitymonitor and mobile device functions on the collected data are possible.

In a further embodiment, a wearable physiology monitor, activity sensor71, or mobile device 72 worn or held by the patient 10, or otherwise beused proximal to the patient's body, can be used to first obtain andthen work collaboratively with a more definitive (medical grade) monitorrecorder 14 to enable the collection of physiology by the monitorrecorder 14 before, during, and after potentially medically-significantevents. The wearable physiology monitor, activity sensor 71, or mobiledevice 72 must be capable of sensing cardiac activity, particularlyheart rate or rhythm, or other types of physiology or measures, eitherdirectly or upon review of relayed data. Where the wearable physiologymonitor or activity sensor 71 is paired with a mobile device 72, themobile device 72 serves as a relay device and executes an applicationthat will trigger the dispatch of a monitor recorder 14 to the patient10 upon detecting potentially medically-significant events in the dataprovided by the paired activity monitor, such as cardiac rhythmdisorders, including tachyarrhythmias and bradyarrhythmias, which arereadily identifiable respectively based on abnormally rapid or slowheart rate. If the mobile device 72 is itself performing the monitoringof the patient's physiology, the mobile device 72 executes anapplication that will trigger the dispatch of a monitor recorder 14 tothe patient 10 in near-real time upon detecting potentiallymedically-significant events, thereby avoiding the delay incurred bydata relay from an activity monitor. Finally, if the wearable physiologymonitor or activity sensor 71 has sufficient onboard computationalresources and also is equipped with a wireless communications servicestransceiver, the wearable physiology monitor or activity sensor 71effectively becomes the mobile device 72 and executes an applicationthat will trigger the dispatch of a monitor recorder 14 to the patient10 in near-real time upon detecting potentially medically-significantevents without the need to first interface with a mobile device 72.Still other configurations of the detection application are possible.

The act of triggering the dispatch of a monitor recorder 14 representsthe first step in a cascade of possible medical interventions ofpotentially increasing seriousness and urgency. Sensors 71 and devices73 are generally considered not to be capable of detecting and recordingmedically precise and actionable data, whereas, as a device designed andapproved for extended wear, the monitor recorder 14 continually monitorsthe patient's physiology over a long time period and will capture anymedically-actionable data leading up to, throughout the occurrence of,and following an event of potential medical concern.

The monitoring data recorded by the monitor recorder 14 can be uploadeddirectly into the patient's EMRs 74, either by using a mobile device 72as a conduit for communications with a server 62 coupled to a securedatabase 64 within which the patient's EMRs 74 are stored, or directlyto the server 62, if the monitor recorder 14 is appropriately equippedwith a wireless transceiver or similar external data communicationsinterface, as further described infra. Thus, the data recorded by themonitor recorder 14 would directly feed into the patient's EMRs 74,thereby allowing the data to be made certifiable for immediate use by aphysician or healthcare provider. No intermediate steps would benecessary when going from cutaneously sensing cardiac electric signalsand collecting the patient's physiology using a monitor recorder 14 topresenting that recorded data to a physician or healthcare provider formedical diagnosis and care. The direct feeding of data from the monitorrecorder 14 to the EMRs 74 clearly establishes the relationship of thedata, as recorded by the monitor recorder 14, to the patient 10 that thephysician is seeing and appropriately identifies any potentiallymedically-significant event recorded in the data as originating in thepatient 10 and nobody else.

Based on the monitoring ECG and physiology data, physicians andhealthcare providers can rely on the data as certifiable and candirectly proceed with determining the appropriate course of treatmentfor the patient 10, including undertaking further medical interventionsas appropriate. The server 62 executes a patient diagnosis program 78(“Dx”) or similar application that can evaluate the recorded physiology79, as fed into the patient's EMRs 74. The patient diagnosis program 78compares the recorded physiology 79 of each patient to a set of medicaldiagnostic criteria 80, from which a diagnostic overread 82 isgenerated. Each diagnostic overread 82 includes one or more diagnosticfindings 81 that are rated by degree of severity. If at least one of thediagnostic findings 81 for a patient exceed a threshold level oftolerance, which may be tailored to a specific client, disease ormedical condition group, or applied to a general patient population, areferral 83, which can include orders to seek immediate treatment, isgenerated on behalf of the patient to a pre-identified care provider formedical care and the patient is notified.

The referral 83 is an actionable, health condition-specific form ofcommunication that is electronically dispatched directly to a careprovider. The care provider is reached through a care provider networkserver 84, or other patient referral system, that executes an externalpatient care program (“Ext”) and which interfaces over the network 61 tothe patient diagnosis program 78 executing on the server 62. In afurther embodiment, the care provider and patient could also be reachedusing social media, provided the necessary patient privacy permissionsare in place. The referral 83 represents a request on behalf of thepatient to an appropriate type of care provider, which could be ageneral practice physician if the patient's physiology 79 representsnormal tracings or a medical specialist, for instance, a cardiacelectrophysiologist referral when the physiology 79 includes adiagnostic finding 81 of an event of sufficient potential severity towarrant the possible implantation of a pacemaker for heart block or adefibrillator for ventricular tachycardia. A further example would bethe direct referral to a cardiologist for the finding of atrialfibrillation for the initiation of blood thinners and possibly anablation procedure.

Other uses of the data recorded by the monitor recorder 14 and otherdevices are possible. For instance, a patient 10 who has previouslysuffered heart failure is particularly susceptible to ventriculartachycardia following a period of exercise or strenuous physicalactivity. A wearable sensor 71 or device 73 that includes a heart ratemonitor would be able to timely detect an irregularity in heart rhythm.The application executed by the sensor 71 or device 73 allows thosedevices to take action by triggering the dispatch of a monitor recorder14 to the patient 10, even though the data recorded by the sensor 71 ordevice 73 is itself generally medically-insufficient for purposes ofdiagnosis and care. Thus, rather than passively recording patient data,the sensor 71 or device 73 takes on an active role in initiating theprovisioning of medical care to the patient 10 and starts a cascade ofappropriate medical interventions under the tutelage of and followed byphysicians and trained healthcare professionals.

In a still further embodiment, the monitor recorder 14 could upload anevent detection application to the sensor 71 or device 73 to enablethose devices to detect those types of potentially medically-significantevents, which would trigger the dispatch of a monitor recorder 14 to thepatient 10. Alternatively, the event detection application could bedownloaded to the sensor 71 or device 73 from an online applicationstore or similar online application repository. Finally, the monitorrecorder 14 could use the sensor 71 or device 73 to generate anappropriate alert, including contacting the patient's physician orhealthcare services, via wireless (or wired) communications, upondetecting a potentially medically-significant event or in response to apatient prompting.

The patient 10 could be notified by the sensor 71 or device 73, throughthe sensor's or device's user interface, that an event of potentialmedical concern has been detected coupled with an offer to have amonitor recorder 14 sent out to the patient 10, assuming that thepatient 10 is not already wearing a monitor recorder 14. Alternatively,the sensor 71 or device 73 could unilaterally send out a request for amonitor recorder 14. The request for a monitor recorder 14 could be sentvia wireless (or wired) communications to the patient's physician, amedical service provider organization, a pharmacy, an emergency medicalservice, or other appropriate healthcare entity that would, in turn,physically provide the patient with a monitor recorder 14. The patient10 could also be told to pick up a monitor recorder 14 directly from oneof the above-identified sources.

Conventional Holter monitors, as well as the ZIO XT Patch and ZIO EventCard devices, described supra, are currently available only by aphysician's prescription for a specific patient 10. As a result, thephysiological data recorded by these monitors and devices are assumed byhealthcare professional to belong to the patient 10. In thisprescriptive medicine context, grave questions as to the authenticity ofthe patient's identity and the data recorded do not generally arise,although current medical practice still favors requesting affirmativepatient and caregiver identification at every step of healthcareprovisioning. As a device intended for adoption and usage broader thanprescriptive medicine, the monitor recorder 14 carries the potential tobe used by more than one individual, which can raise concerns as to theveracity of the data recorded.

In a still further embodiment, the mobile device 72, or, if properlyequipped, the activity monitor, can be used to help authenticate thepatient 10 at the outset of and throughout the monitoring period. Themobile device 72 (or activity monitor) must be appropriately equippedwith a digital camera or other feature capable of recording physicalindicia located within the proximity of the mobile device 72. Forinstance, the Samsung Galaxy S5 smartphone has both a biometricfingerprint reader and autofocusing digital camera built in. Uponreceipt of a monitor recorder 14, the patient 10 can use thephotographic or other recording features of the mobile device 72 (oractivity monitor) to physically record the placement and use of themonitor recorder 14. For instance, the patient 10 could take a pictureor make a video of the monitor recorder 14 using as applied to the chestusing the built-in digital camera. The patient 10 could also swipe afinger over the biometric fingerprint reader. Preferably, the patient 10would include both his or her face or similar uniquely-identifying marksor indicia, such as a scar, tattoo, body piercing, or RFID chip, plusany visible or electronic indicia on the outside of the monitorrecorder's housing, as further described infra with reference to FIG. 5,in the physical recording. The physical recording would then be sent bythe mobile device 72 (or activity monitor) via wireless (or wired)communications to the patient's physician's office or other appropriatecaregiver, thereby facilitating the authentication of the data recordedby the monitor recorder 14. Alternatively, the physical recording couldbe securely stored by the monitor recorder 14 as part of the monitoringECG and physiology data set.

The mobile device 72 could also serve as a conduit for providing thedata collected by the wearable physiology monitor or activity sensor 71to the server 62, or, similarly, the wearable physiology monitor oractivity sensor 71 could itself directly provide the collected data tothe server 62. The server 62 could then merge the collected data intothe wearer's EMRs 74 in the secure database 64, if appropriate (andpermissible), or the server 62 could perform an analysis of thecollected data, perhaps based by comparison to a population of likewearers of the wearable physiology monitor or activity sensor 71. Stillother server 62 functions on the collected data are possible.

Finally, the monitor recorder 14 can also be equipped with a wirelesstransceiver. Thus, when wireless-enabled, both wearable physiologymonitors, activity sensors 71, and mobile devices 72 can wirelesslyinterface with the monitor recorder 14, which could either provide dataor other information to, or receive data or other information from aninterfacing device for relay to a further device, such as the server 62,analysis, or other purpose. In addition, the monitor recorder 14 couldwirelessly interface directly with the server 62, personal computer 69,or other computing device connectable over the network 61, when themonitor recorder 14 is appropriately equipped for interfacing with suchdevices. In one embodiment, network 61 can be a telecommunicationsnetwork, such as the Internet or a cellular network, and the wirelesstransceiver can have at least some cellular phone capabilities, such asby being able to connect to the telecommunications networks. Forexample, if implemented using the standard such as Bluetooth® 4.2standard or a Wi-Fi standard, the transceiver can connect to theInternet. Similarly, if implemented using a cellular standard andincluding a cellular chipset, the transceiver can connect to a cellularnetwork as further described below. Once connected, the monitor recorder14 can interface with the above-described devices via connecting to thetelecommunications network. Still other types of remote interfacing ofthe monitor recorder 14 are possible.

The wearable monitor 12 records a patient's cardiac activity, with anemphasis on sensing atrial activity and, to a lesser extent, ventricularactivity, over an extended period of monitoring. The wearable monitor 12could include additional sensors to monitor and record other types ofphysiology, including blood pressure, respiratory rate, temperature, andblood glucose, either in addition to or in lieu of heart rate. FIG. 7 isa process flow diagram showing a method 100 addressing medicalconditions through a wearable health monitor 12 with the aid of adigital computer 62 in accordance with one embodiment. The method 100can be implemented with the aid of software, firmware or hardware andexecution of the method 100 can be performed in salient part on adownload station 65, which could be a programmer or other device, or adigital computer, including a server 62 or personal computer 76, as aseries of process or method modules or steps. For convenience, themethod 100 will be described in the context of being performed by adigital computer. Execution of the method 100 by other types ofcomputing devices would be analogous mutatis mutandis.

At the outset, a patient suffering symptoms indicative of a non-urgentphysical ailment or health condition (step 101) will obtain a wearablemonitor 12, or similar device, and initiate self-monitoring (step 102).The wearable monitor 12 will record the patient's ECG and physiologydata over a monitoring period and the data will be recorded into anonboard memory. Upon completion of the monitoring period, the ECG andphysiology data will be downloaded into a digital computer with, forinstance, the assistance of a download station 65 or similar device, orvia wireless connection, if the wearable monitor 12 is so equipped.

The ECG and physiology data 79 retrieved from the wearable monitor 12 isevaluated to identify situations in which the patient requires specificactionable health care. The digital computer generates a diagnosticoverread (step 103) of the ECG and physiology data 79 by comparing thedata to a set of diagnostic criteria 80. The ECG and physiology data 79may be structured along a temporal spectrum that reflects changes inphysiology over time, or could be structured on a per event basis wherea change in physiology alone suffices to raise a concern. A diagnosticcriteria 80 can be defined generally for classes of health conditions,such as cardiac disorder, respiratory distress, hypoglycemia, andhypoxia, or for specific medical conditions, for instance, lightheadedness that consists of near syncope, atrial fibrillation thatconsists of episodes longer than 1 minute, ectopy that consists, onaverage, of over 3 PVCs per minute, palpitations that consist of rapidfluttering over the left side of the chest, supraventricular tachycardiathat consists of rates greater than 180 bpm, ventricular tachycardiathat consists of more than 3 ventricular beats in a row, bradycardiathat consists of pauses greater than 3 seconds, or heart blockage thatconsists of unconducted normal sinus impulses. Other diagnostic criteriaare possible.

Diagnostic findings 81 are made for each of the diagnostic criteria 80.The diagnostic findings 81 are rated by the digital computer by degreeof severity and compared to a threshold level of tolerance for eachfinding. The diagnostic findings 81 may be tailored to a specificclient, disease or medical condition group, or applied to a generalpatient population. If any of the diagnostic findings 81 rate severelyenough to warrant medical attention, a referral 83 is automaticallygenerated on behalf of the patient to a pre-identified care provider(step 104) primarily when the patient's medical condition is novel andhas not previously been noted in the patient's medical history, althougha referral may still be appropriate in some situations where the medicalcondition has already presented. When the patient's medical condition ispre-existing, the patient may be told to seek immediate medicaltreatment with a pre-identified medical facility (step 105), therebybypassing the sequential and laggard referral route, although a referraland immediate medical treatment could both be triggered regardless ofmedical condition, should the patient so desire, regardless ofmonitoring outcome. In this instance, where the monitor shows onlynormal activity or unactionable activity, the patient will likely bereferred to a general practitioner.

The foregoing solution to addressing a patient's medical conditions canhappen without having to preemptively involve health insurance.Moreover, the wearable monitor 12 works particularly well with medicalconditions that defy in-clinic testing. In addition, a database ofpre-identified care providers ordered by medical specialty or otherselection criteria can be paired with the diagnostic criteria to ensurethat a patient gains access to the appropriate type of medical carerequired based on the diagnostic findings made for his medicalcondition. In a further embodiment, quality assurance can be performed(step 106) following the dispatch of a referral to rate the health carereceived by the patient using metrics such as quality, efficiency, andexpediency. Other quality assurance metrics are possible. Still otheroperations and steps are possible.

While the invention has been particularly shown and described asreferenced to the embodiments thereof, those skilled in the art willunderstand that the foregoing and other changes in form and detail maybe made therein without departing from the spirit and scope.

What is claimed is:
 1. A health monitoring apparatus for addressingmedical conditions with the aid of a digital computer, comprising: awearable health monitor comprising: a disposable extended wear electrodepatch comprising: a flexible backing comprising stretchable materialdefined as an elongated strip with a narrow longitudinal midsection,each end of the flexible backing comprising an adhesive contact surfaceadapted to serve as a crimp relief; a plurality of electrocardiographicelectrodes comprised on the contact surface of each end of the flexiblebacking and provided to sense a patient's physiology over a monitoringperiod, each electrocardiographic electrode conductively exposed fordermal adhesion and adapted to be positioned axially along the midlineof the sternum for capturing action potential propagation; anon-conductive receptacle affixed to a non-contacting surface of theflexible backing and comprising an electro mechanical docking interface;and a pair of flexible circuit traces affixed at each end of theflexible backing with each circuit trace connecting one of theelectrocardiographic electrodes to the docking interface, at least oneof the circuit traces adapted to extend along the narrow longitudinalmidsection to serve as a strain relief; and a monitor recorder capableof recording the physiology throughout the monitoring period,comprising: a sealed housing adapted to be removably secured into thenon-conductive receptacle; and electronic circuitry comprised within thesealed housing and comprising an external interface configured to beremovably connected to the electrocardiographic electrodes via thedocking interface comprising: an externally-powered microcontrolleroperable to execute under micro programmable control through firmwarethat is stored in a program memory unit of the microcontroller; anelectrocardiographic front end circuit electrically interfaced to amicrocontroller and operable to sense electrocardiographic signalsthrough the electrocardiographic electrodes; and an externally-poweredflash memory electrically interfaced with the microcontroller andoperable to store samples of the electrocardiographic signals collectedduring the execution of the monitoring sequence; a download stationcomprising an interface over which the physiology can be downloaded fromthe onboard memory of the wearable heath monitor upon completion of themonitoring period; and a computer adapted to be interfaced to thedownload station, comprising: a database, comprising: the physiology asretrieved from the download station; and a medical diagnostic criteria;a processor and a memory configured to store code executable by theprocessor and comprising: a comparison module configured to compare thephysiology to the medical diagnostic criteria and to generate adiagnostic overread that comprises one or more diagnostic findings; anda referral module configured to determine the severity of any medicalcondition indicated by the diagnostic findings and to refer the patientto one or more pre-identified care providers via the computer forfacilitated diagnosis as conditioned upon the severity of each suchmedical condition that exceeds a threshold tolerance level.
 2. A healthmonitoring apparatus according to claim 1, the monitor recorder furthercomprising: the microcontroller operable to detect theelectrocardiographic electrodes being adhered to the sternum based onthe sensed electrocardiographic signals and to start an execution of amonitoring sequence stored as part of the firmware based on the detectedadherence.
 3. A health monitoring apparatus according to claim 2,further comprising: a wireless transceiver electrically interfaced withthe microcontroller and operable to wirelessly interface with one ormore external wireless-enabled devices.
 4. A health monitoring apparatusaccording to claim 3, wherein one of the wireless-enabled devices is amobile phone and the wireless transceiver interfaces with the mobilephone via a telecommunications network.
 5. A health monitoring apparatusaccording to claim 4, wherein the wireless-enabled device communicatesthe received samples to the computer to evaluate to evaluate the samplesof the electrocardiographic signals and to refer the patient to the oneor more pre-identified care providers.
 6. A health monitoring apparatusaccording to claim 1, the referral module further comprising at leastone of: a notification module configured to notify a general practicephysician upon a diagnostic finding comprising normal physiological datadespite patient complaints of light headedness or syncope; anotification module configured to notify a cardiologist upon adiagnostic finding comprising atrial fibrillation of over 1 minuteduration, ectopy comprising more than 3 PVCs per minute, palpitationscomprising fluttering of the chest, and supraventricular tachycardiacomprising heart rates over 180 bpm; and a notification moduleconfigured to notify an electrophysiologist upon a diagnostic findingcomprising ventricular tachycardia comprising 3 or more consecutiveabnormal ventricular beats, bradycardia comprising pauses greater than 3seconds, and heart blockage comprising the non-conduction of any normalsinus beat.
 7. A health monitoring apparatus according to claim 1, thedatabase further comprising the pre-identified care providers ordered bymedical specialty and paired with one or more of the diagnosticcriteria.
 8. A health monitoring apparatus according to claim 1, thedatabase further comprising a medical history for the patient, whereinthe medical history is incorporated into the comparison against thediagnostic criteria.
 9. A health monitoring apparatus according to claim8, the referral module further comprising: a notification moduleconfigured to generate a referral to one such care provider if thediagnostic findings comprises a medical condition not found in thepatient's medical history; and a notification module configured toengage proactive health care management if the diagnostic findingscomprises a medical condition found in the patient's medical history.10. A health monitoring apparatus according to claim 1, the databasefurther comprising at least one of: the diagnostic criteria along atemporal spectrum comprising changes in the physiology for at least oneof the diagnostic findings over time; and the diagnostic criteria on aper event basis comprising a change in the physiology for at least oneof the diagnostic findings.